510(k) · Cleared
Recalled · Class II · 2016Neoblue Blanket Led Phototherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical Incorporated · LBI Unit, Neonatal Phototherapy
Cleared on May 13, 2011 as substantially equivalent to K901987 (Olympic Medical Corp., 1990) and 2 other predicates after a 157-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- May 13, 2011
- Review
- 157 days
- Class
- Class II
- Product code
- LBI
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 3 generations to K940996 (1994). 6 ancestors in all, the oldest K901987 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK940996 Olympic Bili-LiteOlympic Medical Corp. · 1994
- 2 generations backK022196 Natus Blue Light Phototherapy UnitNatus Medical, Inc. · 2002 · Recalled
- 1 generation backK051869 Neoblue Cozy Led Phototherapy SystemNatus Medical, Inc. · 2005
- This deviceK103589 Neoblue Blanket Led Phototherapy SystemNatus Medical Incorporated · 2011
- Descendant · cites it directly · 0 of its ownK182178 neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK163526 Bilicocoon™ Phototherapy SystemNeomedlight · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940996 | Olympic Bili-Lite | Olympic Medical Corp. | 1994 | — |
| −2 | K022196 | Natus Blue Light Phototherapy Unit | Natus Medical, Inc. | 2002 | 5 |
| −1 | K051869 | Neoblue Cozy Led Phototherapy System | Natus Medical, Inc. | 2005 | — |
| 0 (this device) | K103589 | Neoblue Blanket Led Phototherapy System | Natus Medical Incorporated | 2011 | — |
| +1 | K182178 | neoBLUE blanket LED Phototherapy System | Natus Medical Incorporated | 2018 | — |
| +1 | K163526 | Bilicocoon™ Phototherapy System | Neomedlight | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LBI device
- #1 K251308 SnugLit (TM) Wearable Phototherapy System…score 11.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K901987 | Olympic Bili-Lite-Pad (TM)Summary page 1…t Name: Classification: Class 2, Product Code LBI, 21CFR Part 880.5700 3. Predicate Device(s): Olympic Bili-Lite Pad (K901987) Natus neoBLUE cozy LED Phototherapy System (K051869) BiliS… | 1990 |
| * | K051869 | Neoblue Cozy Led Phototherapy SystemSummary page 1…BI, 21CFR Part 880.5700 3. Predicate Device(s): Olympic Bili-Lite Pad (K901987) Natus neoBLUE cozy LED Phototherapy System (K051869) BiliSoft Phototherapy System (K053568) 4. Device Description: A neonatal photothe… | 2005 |
| * | K053568 | Bilisoft Phototherapy SystemSummary page 1…te Pad (K901987) Natus neoBLUE cozy LED Phototherapy System (K051869) BiliSoft Phototherapy System (K053568) 4. Device Description: A neonatal phototherapy system composed of a mobile light… | 2006 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 28, 2016 | Class II | Z-0770-2017 | Device Design | neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection of pad and box. |
| Sep 16, 2016 | Class II | Z-0769-2017 | Device Design | The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August 2016. The reliability update to prevent the early failure of the fiberoptic pads… |
| Mar 16, 2015 | Class II | Z-1412-2015 | Other | neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system fiberoptic pads. These failures involve discoloration and melting of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K182178 (Natus Medical Incorporated, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LBI devicesLBI Unit, Neonatal Phototherapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LBI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LBI
134in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBI
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBI
3in 2025
MAUDE reports naming product code LBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 91 | 0 | 1 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 2 | — | 1 | 4 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 3 | 157 | 0 | 5 |
| 2012 | 5 | 108 | 0 | 3 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 1 | — | 1 | 5 |
| 2015 | 1 | — | 1 | 6 |
| 2016 | 3 | 134 | 2 | 22 |
| 2017 | 2 | — | 0 | 577 |
| 2018 | 2 | — | 0 | 37 |
| 2019 | 1 | — | 1 | 6 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The neoBLUE blanket LED Phototherapy System is intended for the treatment of
neonatal hyperbilirubinemia. It can be used in the clinical setting or in the home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103589: Neoblue Blanket Led Phototherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103589
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026